(Associate) Manager Analytical Development Cell Therapy
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Our team is expanding and embarking on a demanding and very exciting development journey. We are seeking an experienced people leader with expertise in Analytical Development to join our efforts to develop cell-based therapies in Denmark. Come and join our Cell Therapy Analytics and Formulation Department within Cell Therapy CMC at Novo Nordisk. The position In the field of cell therapy, drug products are typically the result of long and complex in vitro differentiation protocols, which have a profound impact on the functional properties of cellular products. Development of fit-for-purpose methods and biological characterization are essential to assure adequate quality of Drug Products and implementation and control of the manufacturing process in a production plant. It should be emphasized that the position is located in the greater Copenhagen area. As an experienced leader you will lead a team of analytical scientists to drive the development of complex biological assays for several cell-based Drug Products. Through your in-depth understanding of analytical development methodologies from the Cell Therapy or Biologics field, you will be a key player in progressing product understanding throughout different clinical development phases. Your key responsibilities will include: • Overseeing method development, qualifications and tech transfers and scientifically guiding scientists to deliver to project demand • Interact closely with other associate managers in the department, such Assay Services and Formulation Development and closely align with Analytical Leads on project deliverables • Being involved in CMC strategies of various cell therapy solutions • Collaborating with other departments within Cell Therapy R&D, such as Research, Quality Assurance and GMP Manufacturing Qualifications You hold a PhD degree in cell biology, biotechnology, or a similar field of studies with more than 5 years of experience in the biotechnology or pharmaceutical industry in the area of cell therapy or biologics. You have a strong scientific background in cellular biology and cell culture systems, as well as assay development. The ideal candidate will possess: • Experience in a CMC department, Quality Control and in defining product specifications with respect to QTPPs • Experience in formal line management in the pharmaceutical industry • A strong scientific background in cellular biology and cell culture systems, as well as assay development • A good understanding of regulatory requirements for method validation under GMP • Ability to analyse and interpret data using appropriate statistical models (e.g. Design of Experiments, mixed model analysis), as well as proficiency with statistical software • Working experience in international matrix organizations and Quality systems Personally, this position requires you to be a dedicated and result-oriented team player who enjoys working in a young, innovative, international, and open-minded environment. You excel in multi-tasking, line management, stakeholder management, can easily collaborate cross-departmentally, and are used to clearly present scientific data. About the department The department of Cell Therapy Analytics and Formulation has been established in 2020 and is part of Novo Nordisk’s Cell Therapy R&D unit, where we develop novel cell replacement therapies for the treatment of serious chronic diseases. Our department focuses on the development of Analytical methods and characterization of Cell Therapy Processes. This position is the result of a recent restructuring of the department into dedicated teams. We assure the control of manufacturing processes across the entire pluripotent stem cell workflow. Diabetes mellitus type 1, Parkinson’s disease and chronic heart failure are only some of the indications currently in the pipeline. You will join an international and dedicated Cell Therapy CMC division of ~80 employees, including scientists, project leaders and laboratory technicians. We have expertise in analytical development, bioprocess development, stem cell biology and GMP compliance and truly believe that cell therapies will make a difference in the lives of patients. If this awakens your interest, please apply and support us in translating stem cell-based products into clinical development. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Deadline 07 July 2023 Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 2.6.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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